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Phase 1
Age: 18Years - 75Years
All Genders
ID07242469

Evaluating Safety and Effects of MK-1403 with Additive Coformulation in Adults Living with Type 2 Diabetes

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-31

52

Participants Needed

5

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of a study drug called MK-1403 in adults with Type 2 diabetes mellitus T2D. The study also aims to understand how MK-1403 behaves in the body over time pharmacokinetics and its effect on levels of high-sensitivity C-reactive protein hsCRP in the blood. This is a phase 1 clinical trial focused on treatment in adults aged 18 to 75 with T2D. Participants will be assigned randomly to one of four groups receiving either MK-1403 combined with an additive coformulation or a placebo combined with the same additive coformulation. These treatments are taken orally once daily, with two different dosage levels studied sequentially. The study compares the effects and safety of MK-1403 plus the additive at two different doses against placebo plus the additive at matching doses. During the study, participants will be monitored for adverse events and any discontinuation due to side effects for up to 28 days. Researchers will measure changes in hsCRP levels from baseline and examine the concentration of MK-1403 in the blood 24 hours after dosing on Day 14. The trial involves regular assessments to track safety, tolerability, and drug behavior, with the overall participation lasting approximately four weeks.

CONDITIONS

Brief Title

A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)

Research Team

T

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